Table 1.
Baseline characteristics of the patients included in the exploratory analysis.
| Poor response to IS (N = 32)a | Good response to IS (N = 15) | Pb | |
|---|---|---|---|
| Age [Years–Median (IQR)] | 44 (22.7) | 46 (13) | ø |
| Male n (%) | 23 (72) | 9 (60) | ø |
| Ethnicity n (%) | ø | ||
| Asian: Black: White | 4(12.5): 3(9.4): 25(78.1) | 2(13.3): 2(13.3): 11(74.3) | |
| Cause of renal failure n | |||
| DM | – | – | ø |
| APKD | 2 | – | ø |
| GN | 10 | 7 | ø |
| SLE | 1 | 1 | ø |
| HT | 2 | 1 | ø |
| Congenitalc | 8 | 1 | ø |
| TINd | 5 | 1 | ø |
| Cystinosis | 2 | – | ø |
| HUS | – | 1 | ø |
| CNI toxicity | – | 1e | ø |
| Unknown/not recorded | 2 | 2 | ø |
| Transplant history | |||
| Deceased: LRD: LURD | 22: 8: 2 | 6: 6: 3 | ø |
| Previous transplants: 0: 1 | 26: 6 | 14: 1 | ø |
| Time from Tx [years-median (IQR)] HLA MM [Mean (SD)] |
12.8 (14.4) | 16.6 (12.7) | ø |
| Overall | 2.9 (1.4) | 3.3 (1) | ø |
| A: B: | 1.1(0.6): 1.1(0.7) | 1(0.8): 1.3(0.7) | ø |
| DR | 0.7 (0.5) | 1.2 (0.5) | * |
| HLA Ab status | |||
| CRF [Mean (SD)] | 48.1 (13.9)g | 42.7 (37.7) | ø |
| DSA+ n (%) | 17 (53) | 11 (74.3) | ø |
| -Class I: Class II: Both | 10(31): 3(9.7): 4(12.9) | 3(20): 5(33.3): 3(20) | ø |
| -NA | 15 (47) | 4 (26.7) | ø |
| DSA MFIf [Mean (SD)] | 4437 (6627) | 6758 (8998) | ø |
| Enrolment biopsy scores—median | |||
| (IQR) | |||
| C4d glomh | 3 (1) | 3 (1) | ø |
| Banff C4d (PTC) | 2 (2) | 2 (2) | ø |
| Bannf g | 2 (1) | 1(2) | ø |
| Banff ptc | 1 (2) | 1 (1) | ø |
| Banff cg | 2 (2) | 1 (1) | ø |
| Banff cv | 1 (1) | 1.5 (1) | ø |
| Banff ct | 1 (1) | 1 (1) | ø |
| Banff ci | 1 (1) | 1 (1) | ø |
| TA/IF (%) | 25 (14) | 20 (20) | ø |
| Baseline immunosuppression n (%) | |||
| Tac: CsA | 19 (59): 6 (19) | 8 (53): 7 (47) | ø |
| MPA; Azathioprine | 22 (69): 5 (16) | 9 (60): 5 (33) | ø |
| Baseline renal function [Mean (SD)] | |||
| Creatininei | 184.8 (51.7) | 168.7 (44.8) | ø |
| eGFRj | 37.7 (11.6) | 38.6 (11.3) | ø |
| 1/creat slope | −0.15 (0.23) | −0.07 (0.07) | ø |
| Formally deteriorating | 23 (72) | 10 (67) | ø |
| PCRk [Mean (SD)] | 213 (211) | 74 (74) | † |
| PCR >50 | 27 (84) | 8 (53) | * |
| Post-optimization medication | |||
| Tac n (%) | 31 (97) | 15 (100) | ø |
| Tac level [Mean (SD)] | 5.4 (2.7) | 7.0 (2.2) | * |
| MPA n (%) | 30 (94) | 15 (100) | ø |
| MPA dose [mg (SD)] | 953 (493) | 1,000 (422) | ø |
| On ACE-I n (%) | 20 (62.5) | 6 (40) | ø |
| On ARB n (%) | 22 (68.8) | 12 (80) | ø |
All who were eligible for RCT + the patient (G008) who developed a contraindication to Rituximab during phase 1.
P value, comparing good response to optimized IS (N=15) to all poor response to optimized IS, eGFR>20 (N = 32).
Including Alports.
Including chronic pyelonephritis.
Heart transplant recipient.
No HLA Ab data available on 1 recruit.
Cumulative - includes those with DSA = 0.
Scored as C4d PTC.
μmol/L.
mls/min/1.73 m2.
mg/mmol.
P, NS.
P ≤ 0.005.
P < 0.05.
1° renal diagnosis: DM, diabetes mellitus; APKD, adult polycystic kidney disease; GN, glomerulonephritis; SLE, systemic lupus erythematosus; HT, hypertension; TIN, tubulointerstitial nephritis; HUS, haemolytic uraemic syndrome; CNI, calcineurin inhibitor; Tx type: LURD, living unrelated donor; LRD, living-related donor; HLA MM: Number of Class I (A,B) and Class II (DR) mismatches. Two patients (B003 and W007) had their transplants abroad and tissue typing was unavailable. HLA Ab status: CRF, calculated reaction frequency; DSA, donor specific antibody; MFI, cumulative median fluorescence intensity. Means are shown for whole group, including those with MFI of 0. Enrolment biopsy scores: g, glomerular inflammation; ptc, peritubular capillary inflammation; c, chronic scores; TA/IF, tubular atrophy/interstital fibrosis; Immunosuppression: Tac, Tacrolimus; CsA, ciclosporin; MPA, Mycophenolic acid or mycophenolate mofetil. Baseline renal function: eGFR, estimated glomerular filtration rate (4 value MDRD); Formally deteriorating, meet criteria for deteriorating function based on analysis of 1/creatinine plot; Medication: ACE-I, angiotensin converting enzyme inhibitor: ARB, angiotensin II receptor blocker.